Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)
NCT ID: NCT00745511
Last Updated: 2009-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
96 participants
INTERVENTIONAL
2009-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
2
ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
3
Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
Interventions
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ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
Eligibility Criteria
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Inclusion Criteria
* Subject who are able and willing to comply with the study protocol
* Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye
* Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy
* Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization
Exclusion Criteria
* Patients with severe myocardial disease or coronary occlusion
* Patients with severe personality disorder, suicidal risk or psychosis
* Patients with previous history of CVA
* Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST\>1.5x upper limit of normal value
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications
50 Years
ALL
No
Sponsors
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Ora Bio Ltd.
INDUSTRY
Responsible Party
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Ora Bio Ltd
Principal Investigators
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Itay Chovers, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Barzilai Medical Center
Ashkelon, , Israel
Carmel Medical Center
Haifa, , Israel
Hadassah Medical center Israel
Jerusalem, , Israel
Ziv Medical Center
Safed, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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OB-DAMD-01
Identifier Type: -
Identifier Source: org_study_id
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